NCI Urges Chemo-RT Combination for Invasive Cervical Cancer

NCI Urges Chemo-RT Combination for Invasive Cervical Cancer

BETHESDA, MdThe National Cancer Institute (NCI) has recommended
that oncologists use a combination of chemotherapy and radiation
instead of radiation alone to treat invasive cervical cancer.

In a clinical announcement mailed to cancer specialists, the
Institute cited results from five randomized, phase III studies that
showed clinical benefit for women who received chemotherapy and
radiation given in combination. Until now, surgery or radiation alone
has been the standard treatment for cervical cancer that has spread
locally or regionally.

Standard of Care

The findings of these five trials are remarkably
consistent, said NCI director Richard D. Klausner, MD.
They are likely to change the standard of care for invasive
cervical cancer.

Three of the studies compared chemotherapy-radiation combination
regimens against radiation alone. In all three trials, the
proportion of women alive after about 3 years follow-up was higher in
the groups receiving chemotherapy plus radiation than in those
receiving only radiation therapy, the NCI said in announcing
its recommendation.

In the two other studies, all patients received concomitant
chemotherapy and radiation. However, the chemotherapy drugs differed
between the arms. In one arm of each of these trials, the
chemotherapy used was hydroxyurea (Hydrea) while in the other arms,
the chemotherapy included cisplatin (Platinol). In both trials, the
groups who received cisplatin had better survival rates.

Significant Results With Cisplatin

Although the best chemotherapy regimen for cervical cancer has not
been determined, significant results were seen using cisplatin
alone or cisplatin in combination with 5-FU [5-fluorouracil] and
other agents, the NCI said in its mailing to physicians.

A total of 1,894 cervical cancer patients participated in the five
studies, which were carried out around the country by three of
NCIs clinical trials cooperative groups.

None of the five studies had been published in peer-reviewed journals
at the time the NCI dispatched its letter. Three were in press at the New
England Journal of Medicine but available on its website (www.nejm.org);
one was in review at the Journal of Clinical Oncology; and
data from the fifth was scheduled for presentation at the Society of
Gynecologic Oncology (SGO) annual meeting in late March of this year.

NCI said its recommendation applied to women diagnosed with
International Federation of Gynecologists and Obstetricians (FIGO)
stages IB-IVA cervical cancer, as well as women with stage IA and IIA
cancer who have metastatic disease in the pelvic lymph nodes,
positive parametrial disease, or positive surgical margins.

Side effectsmostly leukopenia, nausea, and vomitingwere
more frequent and more severe in women who received the combination
therapy than in women who were treated with radiation only, the NCI
said. In general, these adverse effects were temporary and manageable.